OPINIONs 009: May 10, 2017

Summary

Blatant disregard for preventing conflict of interest in the editorial process of the specialty journal Fertility & Sterility and its editorial leadership threatens the entire IVF community, with patients on the losing end.

A big part of the current poisonous political atmosphere in the U.S. is the responsibility of media companies, which have abandoned even-handedness in coverage of political events. That media take sides in political discourses is nothing new, but identification of a media outlet with a political party or opinion used to be restricted to editorial pages or editorial comments on television, clearly identified as such. Coverage of news was, still, expected to be non-partisan.

This clear distinction between objective reporting of news and political editorial opinions has in recent years almost completely disappeared from newspapers, television and especially in news coverage on the Internet. The reason is not only that political biases have invaded news coverage but, even more importantly, that media outlets selectively cover news that fit their political bend, while ignoring news that contradicts their philosophy. The result of these developments has been record-low trust by the public in the news media and the recent popularity of the term “fake news.”

Readers may wonder why we, suddenly, here are addressing “fake news,” and what all of that may have to do with what the VOICE usually covers? The answer is that it is finally time to speak up about Fertility & Sterility, the official organ of the American Society for Reproductive Medicine (ASRM), which has been “hijacked” by an editorial leadership that has abandoned all objectivity in selection of materials for publication, and very obviously favors a small group of closely connected insiders with often shared commercial interests.

The May 2017 issue of the journal, finally, made it impossible to remain quiet: It not only reflected a new peak in how unabashed senior editors of the journal (for years) have been promoting their own interests in preferentially allowing business partners, spouses and otherwise associated parties to publish in the journal, but also how, without embarrassment (on more than one occasion), editors declared a study from their own institution as the journal’s “seminal contribution” of the month. Most serious editors of medical journals, possibly except for opinion pieces (i.e., editorial opinions), do not even allow submissions from their own departments. There are enough other publication opportunities available for serious scientists to publish in, if one wishes to avoid even the appearance of favoritism.

This is, however, not even the most deplorable aspect of the current editorial management of Fertility & Sterility. Much more dangerous is the “fake news” the journal spews by aggressively promoting by evidence unsupported practices, but rejecting (often even without outside review) even well-supported manuscripts with opposing data and/or opinions.

It does not help that as principal owner and administrative leader of what claims to be the world’s largest IVF corporation, with centers all over the world (now also including the U.S.), a senior editor simply cannot avoid commercial conflicts of interest. Those conflicts are further aggravated when the journal preferably publishes the editor’s employees’ and business partners’ manuscripts, and offers articles that favor commercial interests in which the editor and/or his company hold ownership, while rejecting (often without outside review) manuscripts hostile to those interests. That the leadership of ASRM would even tolerate appearance of such conflicts of interest is astonishing. That it allowed appearance to progress to current levels of obvious certainty, finally reaching a crescendo with the May issue of Fertility & Sterility, is inexcusable!

Among a whole series of citable examples, two such conflicts of interest deserve special attention: The first involves time-lapse imaging, which several years ago entered the IVF field with much pomposity and a very aggressive marketing effort by two commercial companies. Above noted editor’s company held ownership interests in both. To this day, Fertility & Sterility published the only prospectively randomized study claiming IVF outcome benefits from time-lapse imaging. Noteworthy, the editor’s own IVF company performed the study, and no other study has been able to confirm IVF outcome benefits from time-lapse imaging ever since. Critical studies of time-lapse imaging, even when submitted by highly reputable academic embryologists, were, however, rejected, and, as we repeatedly were told, without outside review. Also suggesting no benefits for IVF outcomes, a prospectively randomized study from CHR experienced the same fate. As both companies peddling these goods were sold off, and marketing dollars got sparser, little has been heard about time-lapse imaging anymore. Yet, IVF centers in the meantime have spent millions of dollars on these expensive toys.

The most important and clearly most consequential procedure Fertility & Sterility has been promoting in radically biased ways, however, is preimplantation genetic screening (PGS). Dedicating in the May 2017 issue not fewer than nine articles to the subject, including six invited opinion pieces in the monthly Views and Reviews section, not one came from an individual critical of the reliability and/or clinical value of PGS, even though the recommended utilization of PGS has undergone truly revolutionary changes over the last few months, as even the most ardent proponents of PGS no longer were able to maintain the hypothesis that PGS could reliably differentiate between clearly euploid and aneuploid embryos, and really improve clinical pregnancy and live birth rates.

Contrast that with the May 2017 issue of Focus on Reproduction, the official monthly magazine of the European Society for Human Reproduction and Embryology (ESHRE), which presented not only a very balanced review on the currently very widely discussed differences of opinion about PGS, fairly referencing proponents and opponents, but also an equally balanced article on “add-on” treatments to IVF, including PGS and time-lapse imaging, which, in contrast to the U.S., in the U.K. have become very controversial.

The difference between the positions staked out by ESHRE and ASRM is, therefore not only striking but highly consequential because, with the official organ of the ASRM taking such a one-sided view on PGS, the society basically endorses the utilization of PGS. Since PGS is ineffective in improving IVF outcomes and, at least in women with low functional ovarian reserve, likely, reduces live birth chances because of disposal of potentially normal embryos (false positive PGS), we consider it incomprehensible that the ASRM leadership tolerates the current editorial policy at Fertility & Sterility.

Remarkably, not one published article among all the PGS papers in the May 2017 issue of the journal explained the sudden switch in recommended PGS reporting, recently announced by the Preimplantation Genetic Diagnosis International Society (PGDIS). After IVF centers were advised for years by PGS laboratory reports to discard “aneuploid” embryos, suddenly, that recommendation now is to do so only to embryos with trophectoderm biopsies that are over 80% mosaic-aneuploid. One wonders how many infertile women over all those years disposed of their last pregnancy chances by discarding embryos at the advice of PGS laboratories that, now, are considered transferrable.

Instead of a “mea-culpa” from the PGS laboratory community for all the damage that has been done to infertile women over more than a decade (not even addressing the unwarranted costs they were committed to), as some of the papers in the May 2017 issue of Fertility & Sterility demonstrate, we are once again being exposed to a well-thought-out marketing campaign by laboratory interests. Like, suddenly, PGS 2.0 was born, after PGS 1.0 was finally disclosed as ineffective, so now, that even proponents of PGS 2.0 must again acknowledge that the procedure does not improve pregnancy and live birth rates, the marketing machine goes again into overdrive: Readers will notice that in many of the PGS articles in the May issue of the journal the term PGS is no longer used; suddenly we are back to calling the procedure by a completely different name, “PGD-A” (preimplantation genetic diagnosis for aneuploidy), as if that could hide that the procedure is not only ineffective but often harmful to our patients. And, since claims of improved IVF outcomes are no longer sustainable, PGS/PGD-A, suddenly, has found yet other alleged new indication, as at least one of the papers (again from the senior editor’s own department) claims, shortened time to conception and lower miscarriage rates.

We don’t have the space here to explain why even these newly suggested indications are unsupported by data, but just to mention one obvious point: randomizations are to occur after patient exclusions and not vice-versa, even (or, maybe, especially) if they are done in the editor’s company.

What a shame that ASRM leadership is allowing our journal, Fertility & Sterility, to be “hijacked” for such unsavory purposes!

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